Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction

Phase 4

Completed

• Conditions: ST Elevation Acute Myocardial Infarction
• Interventions: Device: Bioresorbable vascular scaffold; Device: Everolimus eluting stent

• Registration Number: NCT02151929
• Lead Sponsor: San Giuseppe Moscati Hospital

Brief Summary

Evaluation of the feasibility and safety of Bioresorbable Vascular Scaffold (BVS) in patient treated with primary PCI (pPCI).

Detailed Description

Background. Drug-eluting stent (DES) implantation may offer benefits in terms of repeat revascularization in patients with ST elevation myocardial infarction (STEMI). The everolimus eluting bioresorbable vascular scaffold (BVS) has shown efficacy and safety in stable patient but not in acute coronary syndromes. The study tested the feasibility and safety of BVS in patient treated with primary PCI (pPCI) Methods. Consecutive STEMI patients admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary PCI capability will be randomly assigned to everolimus eluting stent (EES) or BVS. Primary endpoints are procedural and clinical success. The MACE (cardiac death, non fatal myocardial infarction, target lesion revascularization (TLR)) and definite or probable ST will be evaluated at six months.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2013-08
• Study Completion: 2014-04
• Status Verified: 2014-05
• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-05-30
• Last Update Submitted: 2014-05-30
• Study First Posted: 2014-06-02
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. chest pain for more than 30 minutes;
2. ST-segment elevation of 1 mm or more in 2 or more contiguous electrocardiograph leads or with presumably new left bundle-branch block

Exclusion Criteria

1. Active internal bleeding or a history of bleeding diathesis within the previous 30 days;
2. Contraindication to dual antiplatelet therapy for 12 months;
3. Known allergy to everolimus;
4. A history of stroke within 30 days or any history of hemorrhagic stroke;
5. History, symptoms, or findings suggestive of aortic dissection;
6. High-likelihood of death within BVS resorbtion time;
7. Cardiogenic shock;
8. Infarct artery reference diameter, <2.0 mm or >3.7 mm (i.e. not suitable for currently available BVS sizes);
9. Pregnancy;
10. Participation in other trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bioresorbable Vascular Scaffold	Bioresorbable vascular scaffold	Implantation of of an everolimus eluting bioresorbable scaffold in patients with STEMI treated with primary PCI
Everolimus Eluting stent	Everolimus eluting stent	Implantation of of an everolimus eluting stent in patients with STEMI treated with primary PCI

Primary Outcome Measures

Name	Time	Method
Procedural and Clinical success	Patients will be followed for the duration of hospital stay (4-8 days)	Procedural success: The deployment of BVS at the intended target lesion with a final residual stenosis ≤20% and a TIMI 2-3 coronary flow by visual estimation without major periprocedural complication (death, emergent CABG, coronary perforation, flow limiting coronary dissection).; Clinical success: any major in-hospital events (deaths, reinfarction, urgent revascularization, stroke, major bleedings)

Secondary Outcome Measures

Name	Time	Method
The MACE	six months	cumulative incidence of cardiac death, non fatal myocardial infarction and target lesion revascularization

Trial Locations

Locations (1)

Division of Cardiology Ao Moscati; 🇮🇹 Avellino, Italy